Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00901823

Enrollment

Registered

2009-05-14

Start date

2011-03-31

Completion date

2011-03-31

Last updated

2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Brief summary

This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Interventions

DRUGDiazoxide choline

A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR

DRUGDiazoxide choline high dose

A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Signed informed consent * Healthy adults * Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5 * Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL

Exclusion criteria

* Known CAD, DM, uncontrolled HTN * Pregnancy or unable to complaint with the birth control method required

Design outcomes

Primary

Measure	Time frame
Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR	35 days

Secondary

Measure	Time frame
Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions	35 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026